Actively Recruiting

Phase 2
Age: 18Years - 76Years
All Genders
NCT06764615

A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)

Led by Takeda · Updated on 2025-12-29

183

Participants Needed

16

Research Sites

239 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Crohn's Disease and Ulcerative Colitis are two types of inflammatory bowel disease (IBD), which is a serious, long-term condition in the gut (intestine) that can cause pain and swelling (inflammation) in the bowel. TAK-279 is a medicine which helps to block inflammation. This study is an extension of the parent studies, TAK-279-CD-2001 (NCT06233461) and TAK-279-UC-2001 (NCT06254950). This means that participants who responded to treatment with TAK-279 in either of the parent studies may be able to continue to benefit from the treatment in this study. The main aim of this study is to find out how safe TAK-279 is for long term use and to check if it reduces bowel inflammation and symptoms when used for a longer period of time in adults with moderately to severely active UC or CD. The participants will be treated with TAK-279 for up to 2 years (108 weeks). During the study, participants will visit their study clinic 11 times.

CONDITIONS

Official Title

A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)

Who Can Participate

Age: 18Years - 76Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to understand and comply with study procedures, including digital tools
  • Provided signed informed consent before starting trial procedures
  • Completed 52 weeks in the parent phase 2 Crohn's Disease or Ulcerative Colitis trials with valid electronic diary data
  • Showed clinical or symptomatic response to TAK-279 treatment by Week 52 in the parent trial
  • Meet contraception recommendations during the study
Not Eligible

You will not qualify if you...

  • Considered unsuitable for the extension study due to compliance or medication adherence concerns
  • History of malignancy or dysplasia during the parent trial or at extension study start
  • Meet specific laboratory exclusion criteria defined by the study protocol
  • Taking oral corticosteroids for Crohn's Disease or Ulcerative Colitis at or after Week 48 of the parent trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

Woodholme Gastroenterology Associates

Glen Burnie, Maryland, United States, 21061

Actively Recruiting

2

Tyler Research Institute, LLC

Tyler, Texas, United States, 75701

Actively Recruiting

3

Chongqing General Hospital

Chongqing, Chongqing Municipality, China, 400013

Actively Recruiting

4

The First Affiliated Hospital of Sun Yat-sen University

Guangdong, Guangdong, China, 510080

Actively Recruiting

5

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China, 510655

Actively Recruiting

6

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China, 2000127

Actively Recruiting

7

Hepato-Gastroenterologie HK s.r.o.

Hradec Králové, Czechia, 500 12

Actively Recruiting

8

Pannonia Maganorvosi Centrum

Budapest, Hungary, 1136

Actively Recruiting

9

St. Antonius Ziekenhuis

Tilburg, North Brabant, Netherlands, 5022GC

Actively Recruiting

10

Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj

Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100

Actively Recruiting

11

Centrum Medyczne MedykSp. z o.o. Sp. K.

Lublin, Poland, 35-326

Actively Recruiting

12

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, Poland, 71-434

Actively Recruiting

13

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Poland, 04-730

Actively Recruiting

14

Endomed

Košice, Slovakia, 4013

Actively Recruiting

15

Inje University Haeundae Paik Hospital

Haeundae, Busan Gwangyeogsi, South Korea, 48108

Actively Recruiting

16

Yonsei University Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea, 220-701

Actively Recruiting

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Research Team

T

Takeda Contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD) | DecenTrialz